Medication info
Duetor Tablet 10/20 Milligrams

Duetor Tablet 10/20 Milligrams

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
(주)서울제약
Appearance
White, biconvex, rectangular, film-coated tablet
Packaging
30 tablets/PTP[(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202101415 · Approved 2021.02.18 · Insurance code 652904520

Summary

Main use
Reduction of cholesterol in primary hypercholesterolemia (homozygous familial) and dyslipidemia, and alleviation of cardiovascular disease risk by increasing HDL.
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dose range is 10/10mg to 10/80mg per day. A starting dose of 10/10mg or 10/20mg daily is recommended. For patients requiring greater (over 55%) reduction in LDL cholesterol, a starting dose of 10/40mg daily is recommended. After starting treatment or adjusting the dose, lipids should be checked with an interval of more than 2 weeks.

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Reduction of cholesterol in primary hypercholesterolemia (homozygous familial) and dyslipidemia, and alleviation of cardiovascular disease risk by increasing HDL.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
  • atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication helps reduce total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol. It is also used as an adjunct or alternative therapy in patients with homozygous familial hypercholesterolemia. This medication should be taken in conjunction with dietary therapy, complementing non-pharmacological measures such as restricting saturated fat and cholesterol intake. It is important to identify and treat secondary causes of dyslipidemia, such as diabetes or hypothyroidism, before treatment. Continuous blood tests for total cholesterol, LDL, HDL, and triglycerides are necessary for effective treatment. This medication is used to lower the risk of vascular diseases related to hypercholesterolemia.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dose range is 10/10mg to 10/80mg per day. A starting dose of 10/10mg or 10/20mg daily is recommended. For patients requiring greater (over 55%) reduction in LDL cholesterol, a starting dose of 10/40mg daily is recommended. After starting treatment or adjusting the dose, lipids should be checked with an interval of more than 2 weeks.

Precautions

This medication may cause serious problems in the muscles, so if sudden muscle pain or weakness occurs, notify your doctor immediately. In particular, if there is a risk of renal function issues due to severe infections, hypotension, major surgery or trauma, severe metabolic abnormalities, or uncontrolled seizures, this medication should be temporarily or permanently discontinued. Patients who are allergic to the ingredients in this medication, those with active liver disease, unexplained elevated liver enzymes, muscle disorders, pregnant or potentially pregnant women, nursing mothers, patients taking certain antivirals, and those with lactose intolerance should not take this medication. Caution should be exercised in patients with a history of alcohol abuse or liver disease, severe liver dysfunction, renal impairment, hypothyroidism, genetic muscle disorders, a previous history of muscle issues caused by similar medications, and the elderly over 70 years of age. Care should also be taken when used in combination with fibrate-class drugs, and patients with severe muscle weakness or ocular muscle weakness should be cautious when taking this medication. Regular liver function tests should be performed while on this medication, and if there are abnormalities in liver function, the medication should be discontinued immediately. Additionally, this medication may slightly elevate blood sugar levels, so patients at risk of diabetes should periodically check their blood sugar. Dizziness may occur while driving or operating machinery, so caution is advised. This medication may be harmful to the fetus during pregnancy, so women who are pregnant or planning to become pregnant should not take it, and women of childbearing age should use appropriate contraceptive methods while taking this medication. Nursing mothers are also advised not to take this medication. The safety and efficacy in children have not been established, so use in children is not recommended. There is no specific antidote for overdose, and treatment should be based on symptoms with monitoring of liver function and muscle enzyme levels. This medication may interact with several other drugs, so be sure to inform your doctor or pharmacist if you are taking other medications.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination changes

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • vomiting
  • diarrhea
  • joint pain
  • musculoskeletal pain
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  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • malaise
  • chest pain
  • discomfort in the chest
  • edema
  • headache
  • constipation
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • pharyngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • paresthesia
  • sensory loss
  • dysgeusia
  • memory loss
  • peripheral neuropathy
  • thrombocytopenia
  • hepatitis

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is preferable to keep the storage temperature between 1 degree and 30 degrees Celsius at room temperature. This way, the effectiveness and safety of the medication can be maintained for a long time.

Appearance and packaging

Appearance

White, biconvex, rectangular, film-coated tablet

Package unit

30 tablets/PTP[(10 tablets/PTP x 3)]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.